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NCT Number: NCT03762083

Clinical Performance of a Vaginal Pessary (pHyph) in Bacterial Vaginosis

This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability, and adverse events (AEs).

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stortorgets Gynekologmottagning, Helsingborg, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult, post-menarchal, pre-menopausal women aged 18 years or older

  • Diagnosis of BV according to Amsel's criteria, defined as having at least 3 of the 4 following criteria:
  • Thin, white, yellow, homogenous discharge
  • Clue cells on microscopy (more than 20 percent of epithelial cells)
  • pH of vaginal fluid above 4.5
  • Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
  • Having decisional capacity and providing written informed consent
  • Negative urine pregnancy test at screening
  • Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
  • Refrain from sexual intercourse or use a condom until Day 7
  • Signed informed consent and willing and able to comply with all study requirements

Exclusion criteria

Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening

  • Anticipated menstruation during the treatment period (Day 0 till Day 7)
  • Patients who are pregnant or breastfeeding
  • Patients who were treated for BV within the past 14 days
  • Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days
  • Patients who have used pH-modifying vaginal products within the last 14 days
  • Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
  • Known/previous allergy or hypersensitivity to any product constituent
  • Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion

Treatment and study plan

pHyph generation I

Device

A vaginal tablet for the treatment of BV with administration every 48 hours.

Other names: Gedea pessary

Primary outcomes

  1. Clinical Cure Rate

    Time frame: Day 7

    Defined as absence of all of the following 3 Amsel criteria:

    • Thin, white, yellow, homogenous discharge
    • Clue cells on microscopy (more than 20% of epithelial cells)
    • Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added

Secondary outcomes

  1. Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1

    Time frame: Day 7 compared to Day 0

    Defined as absence of one of the following Amsel criteria:

    • Thin, white, yellow, homogenous discharge
    • Clue cells on microscopy (more than 20% of epithelial cells)
    • Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added

  2. Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2

    Time frame: Day 7 compared to Day 0

    Defined as absence of one of the following Amsel criteria:

    • Thin, white, yellow, homogenous discharge
    • Clue cells on microscopy (more than 20% of epithelial cells)
    • Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution is added

  3. Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3

    Time frame: Day 7 compared to Day 0

    Defined as absence of one of the following Amsel criteria:

    • Thin, white, yellow, homogenous discharge
    • Clue cells on microscopy (more than 20% of epithelial cells)
    • Release of fishy odour "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added

  4. Usability, Measured by Patient Questionnaire

    Time frame: Day 7

    General assessment of the treatment on a integer scale that ranges from 1 to 10. The lower end of the scale is indicated with the term "Not satisfied" and the higher end with the term "Very satisfied".

    Question asked: How do you generally regard the treatment?

  5. Proportion of Patients Having a Recurrence of the BV

    Time frame: Up to Day 35

    Proportion of patients answering Yes to the question "Have the symptoms recurred?"

Sponsors and collaborators

Lead sponsor

Gedea Biotech AB

Industry

Registry information

Official study title

An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2018
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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